Sophia McGovern
Sophia McGovern is Associate Consultant at Decisive Consulting Ltd.
JournalThe EU’s Health Technology Assessment Regulation: Overview and considerations for regulatory teams
The EU’s Health Technology Assessment Regulation (EU-HTAR) demonstrates a significant transformation in how health technologies are evaluated across EU member states (MS). The regulation, which came into effect on 12 January 2025, establishes a partnership between the European Medicines Agency (EMA) and national Health Technology Assessment (HTA) bodies through introducing joint clinical assessments (JCAs) and joint scientific consultations (JSCs).
JournalA key role for the European Medicines Agency in the European Union’s Health Technology Assessment Regulation
The need for early collaboration between regulators and European Union’s (EU) Health Technology Assessment (HTA) bodies when developing ‘fit-for-purpose’ evidence generation plans has long been acknowledged, and the ‘Health Technology Assessment (EU) 2021/2282’ (EU-HTAR) Regulation will be the first permanent collaboration between the European Medicines Agency (EMA) and HTA ...